New Draft Guidance Documents and an Advance Notice of Proposed Rule-Making

The FDA Center for Tobacco Products posted two Draft Guidance documents and an Advance Notice of Proposed Rule-Making. We encourage you to view the documents and submit your comments. Visit www.fda.gov/tobaccoguidance for more information.

· Draft Guidance for Industry and FDA Staff Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions. This draft guidance provides information in response to frequently asked questions that the Center for Tobacco Products received from manufacturers and other interested stakeholders on demonstrating the substantial equivalence of a new tobacco product. Please submit your comments by November 8, 2011. More information is also available on our Substantial Equivalence webpage

· Draft Guidance for Industry Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products. This guidance is intended to assist persons submitting warning plans for cigarettes and warning plans for smokeless tobacco products. Please submit your comments by November 8, 2011.

· Advance Notice of Proposed Rule-Making (ANPRM): Non-Face-to-Face Sale and Distribution of Tobacco Products and Advertising, Promotion, and Marketing of Tobacco Products. This ANPRM was issued to obtain information related to the regulation of non-face-to face sale and distribution of tobacco products and the advertising, promotion, and marketing of tobacco products. Please submit your comments by December 8, 2011.

Source: FDA Center for Tobacco Products